Senior Large Molecule DS Product Steward

Posted 3 Days Ago
Be an Early Applicant
2 Locations
In-Office
132K-244K Annually
Senior level
Healthtech • Biotech
The Role
Leads technical industrialization and lifecycle management for commercial large-molecule drug substance products. Develops technical roadmaps, manages product and process health, investigates and mitigates technical risks, drives process improvements, supports launches and validation, and represents products in governance forums. Requires expertise in biological molecule manufacturing, process development, technology transfer, process validation, pharmaceutical quality systems, regulatory requirements, and cross-functional technical leadership.
Summary Generated by Built In

PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network.

Within PTT, Roche’s global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams.

The Opportunity

The Senior Large Molecule DS Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification (PPQ), supply maturity and optimization, and ultimately divestment.

Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap) and Product Technical Health Management (Own & Mitigate Technical Risks):

  • Identify, define, and deliver DS-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant.

  • Deliver on the product’s technical strategic roadmap across the commercial lifecycle, as defined by an end-to-end Product Technical Lead, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives.

  • Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle.

  • Represent the product in key technical governance forums and senior stakeholder interactions

Who you are
  • The ideal candidate is a recognized authority in the field, bringing scientific expertise, industrial experience, and leadership capabilities.

  • B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage 

  • Proven record in the Drug Substance or Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules.

  • Demonstrated experience with technology transfer and/or with process validation and in pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing 

  • Strong understanding of regulatory submission and health authority requirements and of of patient needs / patient-centricity as key elements of design and delivery 

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $131,500 to $244,300.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

#LI-PK1

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Skills Required

  • Bachelor’s or master’s degree in a scientific discipline such as biotechnology, pharmacy, or biology
  • At least 7 years of relevant industrial experience in platform-specific process development or manufacturing operations
  • Experience in drug substance or drug product manufacturing and product or technology industrialization for biological molecules
  • Experience with process development for biological molecule platforms
  • Experience with technology transfer and/or process validation
  • Experience with pharmaceutical quality systems and applicable industry guidelines
  • Strong understanding of regulatory submissions and health authority requirements
  • PhD in a relevant scientific discipline

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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